Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 83 of 548
FDA Devices Moderate Apr 3, 2024
SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 5675-76, 13554…
Alcon Research, LLC
FDA Devices Critical Apr 3, 2024
stay-safe /Luer Catheter Ext. 6 in
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Apr 3, 2024
RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part number 28…
Bolton Medical Inc.
FDA Devices Moderate Apr 3, 2024
Thermalon Sinus Compress (French), Item Number 24332F
Bruder Healthcare Company, LLC
FDA Devices Moderate Apr 3, 2024
Thermalon Back Wrap, Item Number 24312
Bruder Healthcare Company, LLC
FDA Devices Moderate Apr 3, 2024
Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225
Baxter Healthcare Corporation
FDA Devices Moderate Apr 3, 2024
Thermalon Sinus Compress, Item Number 24332
Bruder Healthcare Company, LLC
FDA Devices Critical Apr 3, 2024
Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
Boston Scientific Corporation
FDA Devices Moderate Apr 3, 2024
OptiCross Coronary Imaging Catheter, REF H749518080120
Boston Scientific Corporation
FDA Devices Moderate Apr 3, 2024
Insufflation unit, UHI-4.
Olympus Corporation of the Americas
FDA Devices Critical Apr 3, 2024
GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART
DeRoyal Industries Inc
FDA Devices Moderate Apr 3, 2024
VITROS Performance Verifier I
Ortho-Clinical Diagnostics
FDA Devices Moderate Apr 3, 2024
SOLTIVE Pro SuperPulsed Laser (TFL-SLS )
Olympus Corporation of the Americas
FDA Devices Moderate Apr 3, 2024
Thermalon Neck Wrap, Item Number 24322
Bruder Healthcare Company, LLC
FDA Devices Moderate Apr 3, 2024
InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number: LCS1500UNOL LCS1…
Olympus Corporation of the Americas
FDA Devices Moderate Apr 3, 2024
Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers: GK1003, AME Kit 54562 GK1004, KIT LAP CHOL …
Applied Medical Resources Corp
FDA Devices Moderate Apr 3, 2024
Access Substrate, REF 81906, For use with the Access Immunoassay Systems
Beckman Coulter, Inc.
FDA Devices Moderate Apr 3, 2024
Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBIO
Baxter Healthcare Corporation
FDA Devices Moderate Apr 3, 2024
SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
Olympus Corporation of the Americas
FDA Devices Moderate Apr 3, 2024
CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
Philips North America
FDA Devices Moderate Apr 3, 2024
Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) running Software Version Number 4.X
Philips North America
FDA Devices Moderate Apr 3, 2024
Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2…
Randox Laboratories Ltd.
FDA Devices Moderate Apr 3, 2024
Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016
Baxter Healthcare Corporation
FDA Devices Moderate Apr 3, 2024
O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
Emergency Products & Research
FDA Devices Moderate Apr 3, 2024
VITROS Performance Verifier II
Ortho-Clinical Diagnostics
FDA Devices Critical Apr 3, 2024
stay-safe /Luer Lock Catheter Ext. 12 in
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Mar 27, 2024
MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. …
Angiodynamics, Inc.
FDA Devices Moderate Mar 27, 2024
Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm)
D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
FDA Devices Moderate Mar 27, 2024
MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. C…
Angiodynamics, Inc.
FDA Devices Moderate Mar 27, 2024
MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Numbe…
Angiodynamics, Inc.
FDA Devices Moderate Mar 27, 2024
Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"
Mckesson Medical-Surgical Inc. Corporate Office
FDA Devices Moderate Mar 27, 2024
TENSIVE Conductive Adhesive Gel, REF 016-401600
Natus Neurology Inc
FDA Devices Critical Mar 27, 2024
HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. …
Thoratec Corp.
FDA Devices Critical Mar 27, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
Smiths Medical ASD Inc.
FDA Devices Moderate Mar 27, 2024
MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756
Angiodynamics, Inc.
FDA Devices Moderate Mar 27, 2024
Medtronic DLP Vessel Cannula, Model Number REF 30000
Medtronic Perfusion Systems
FDA Devices Moderate Mar 27, 2024
MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Numbe…
Angiodynamics, Inc.
FDA Devices Critical Mar 27, 2024
HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS Implant K…
Thoratec Corp.
FDA Devices Moderate Mar 27, 2024
Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis
Mckesson Medical-Surgical Inc. Corporate Office
FDA Devices Moderate Mar 27, 2024
I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180
In2Bones, SAS
FDA Devices Moderate Mar 27, 2024
impression coping, repositionable, short, screw-retained, PF 4.0
Thommen Medical AG
FDA Devices Moderate Mar 27, 2024
Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645, g) 423667, …
ConvaTec, Inc
FDA Devices Moderate Mar 27, 2024
MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Cata…
Angiodynamics, Inc.
FDA Devices Moderate Mar 27, 2024
Access Total T4, REF 33800, IVD, thyroxine reagent assay.
Beckman Coulter, Inc.
FDA Devices Critical Mar 27, 2024
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
Smiths Medical ASD Inc.
FDA Devices Moderate Mar 27, 2024
natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 024252
Natus Neurology Inc
FDA Devices Moderate Mar 27, 2024
microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, …
Landauer
FDA Devices Moderate Mar 27, 2024
HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's foot for hip surgery
Baxter Healthcare Corporation
FDA Devices Moderate Mar 27, 2024
Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm)
D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
FDA Devices Moderate Mar 27, 2024
MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. …
Angiodynamics, Inc.